checklist before BCG vaccination

Last edited 04/2019

Contraindications

The vaccine should not be given to:

• those who have already had a BCG vaccination
  
  
• those with a past history of TB
  
  
• those with an induration of 5mm or more following Mantoux (AJV) tuberculin skin testing
  • BCG should not be administered to an individual with a positive tuberculin test - it is unnecessary and may cause a more severe local reaction
  • those with a Mantoux (AJV) tuberculin skin test induration of 5mm and greater should be referred to a TB clinic for assessment of the need for further investigation and treatment
    
    
• those who have had a confirmed anaphylactic reaction to a component of the vaccine
  
  
• children less than two years of age in a household where an active TB case is suspected or confirmed
  
  
• infants born to a mother who received immunosuppressive biological therapy during pregnancy
  
  
• those who are receiving, or have received in the past 6 months,
  • immunosuppressive chemotherapy or radiotherapy for malignant disease or non-malignant disorders
  • immunosuppressive therapy for a solid organ transplant (with exceptions, depending upon the type of transplant and the immune status of the patient)
    
    
• those who are receiving or have received in the past 12 months
  • immunosuppressive biological therapy (e.g. anti-TNF therapy such as alemtuzumab, ofatumumab and rituximab) unless otherwise directed by a specialist
    
    
• those who are receiving or have received in the past 3 months immunosuppressive therapy including:
  • Adults and children on high-dose corticosteroids (>40mg prednisolone per day or >2mg/kg/day in children under 20kg) for more than 1 week
  • Adults and children on lower dose corticosteroids (>20mg prednisolone per day or >1mg/kg/day in children under 20kg) for more than 14 days
  • non-biological oral immune modulating drugs e.g. methotrexate >25mg per week, azathioprine >3.0mg/kg/day or 6-mercaptopurine >1.5mg/kg/day
  • for children on non-biological oral immune modulating drugs (except those on low dose) specialist advice should be sought prior to vaccination

BCG vaccine is absolutely contraindicated in all HIV-positive persons

Infants born to HIV positive mothers should only be given BCG vaccination when the exclusively formula-fed infant is confirmed HIV uninfected at 12-14 weeks

• however, infants considered at low risk of HIV transmission (maternal VL <50 HIV RNA copies/mL at or after 36 weeks' gestation) but with a high risk of tuberculosis exposure may be given BCG at birth

Pregnancy and breast-feeding

• BCG vaccination should not be given during pregnancy
• Breast-feeding is not a contraindication to BCG, however if there is any doubt as to whether an infant due to receive BCG vaccine may be immunosuppressed due to the mother's therapy, including exposure through breastfeeding, specialist advice should be sought

Premature infants

• important that premature infants have their immunisations at the appropriate chronological age, according to the schedule
• potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering to very premature infants (born <=28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity
• as the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed (3)
• if in doubt the consult specialist advice

General information:

• vaccine: live attenuated BCG bacterium
• dose: check summary of product characteristics for particular BCG vaccine to be used

Check summary of product characteristics before administration of BCG vaccine.

Reference

1. DOH (25/11/2002). Important Infomation for Medical and Healthcare Professionals about new BCG Vaccine Statens Serum Institut (SSI).PL/CO/2002/1
2. The Green Book. Chapter 19 - Tuberculosis (April 2019)
3. BNF 14.4